Full-Day Workshop at the Anacon/Analytica
Conference, India

Validation
of Analytical Methods for FDA and EU Compliance

Dr. Ludwig Huber,

October 13, 2011,
Mumbai, India

The workshop is dedicated to senior analysts and
laboratory and QA Management of pharmaceutical development and routine
laboratories and for API manufacturers. The workshop will give attendees the
background to understand the requirements and even more importantly it will
focus on strategies and provide tools to implement most critical method
validation requirements. Practical examples and interactive exercises will be
dispersed into and between the presentations. About 50% of the total will be
dedicated to practical sessions with life examples..

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Verification of standard and compendial methods according to
USP <1226>

Recommendations what, when and how to revalidate after
changes according to United States and European Pharmacopeia

Criteria for method adjustments vs. changes and the impact
on revalidation and documentation

Going through seven real world method modifications with and
without the need for revalidation

Development and validation of stability indicating methods
using stress testing

Preparing validation reports in line with regulations and
quality standards
Going through a validation report - from beginning to end
Going through the complete validation package for FDA
submissions and inspections

Seven most common method validation pitfalls and how to
avoid them

Special considerations for methods used for biological fluid
analysis

Who should attend

Laboratory management, supervisors and senior analysts

QA managers and personnel

Regulatory affairs

Consultants

from

Pharmaceutical development

Pharmaceutical manufacturers

API manufacturers

CROS doing clinical studies

Contract laboratories

Regulatory agencies

Laboratory suppliers of material, equipment and services

Agenda

09:30 - 10.00

Registration

10:00 - 10:15

Welcome and Introduction

10.15 - 10:30

FDA/EU, USP and ICH requirements and inspection
reports

US FDA requirements and guidelines

Inspection practices - Examples of FDA Warning
Letters

Understanding the Inspector's questions

USP, ICH and EU Requirements

Terminology: Validation, qualification and
verification

10:30 – 11:30

Validation and test parameters

Validation parameters according to ICH Q2 and USP

Going through 9 ICH test parameters

Selecting test conditions and acceptance criteria
for different sample types

Workshop Exercise and Q&As

11:30 - 12-00

Coffee Break

12:00 – 13:00

Iterative method development and validation

Preparation phase

Validation activities during development

The importance of robustness testing

Executing the tests

Workshop Exercise and Q&As

13:00 – 13.30

Documentation of test results

ICH and FDA requirements for documentation

Going through through a complete validation package

Validation requirements along drug development
phases

Post-validation activities

Workshop Exercise and Q&As

13:30 – 14:30

Lunch Break

14.30 – 15:00

Transfer of Analytical Methods and Procedures

USP <1224> with 4 options for method transfer

Focusing on comparative testing

Examples for testing: FDA guidance as case study

Handling deviations

Workshop Exercise and Q&As

15:00- 15:30

Validation of Compendial Methods

FDA and international requirements

USP <1226> for method verification

Risk assessment as criteria for type and extend of
testing

Examples for verification testing

Workshop Exercise and Q&As

15:30 - 16:00

Method Changes and revalidation

Method changes vs. adjustments

Changes that require revalidation

Practical recommendations from USP <621> and EP 5

Initiating, approving and formally releasing changes

Workshop Exercise and Q&As

16.00 – 16:30

Tea Break

16:30 – 17:00

Validation of Stability Indicating Methods

FDA and International requirements

Forced degradation to generate suitable samples

Strategies and examples for validation and testing

Test procedures and documentation

Workshop Exercise and Q&As

17:00 - 17:30

Special Considerations for methods used for body
fluids

FDA and International requirements

Difference to methods used for APIs and drugs

Test conditions and acceptance criteria

Quality assurance during routine analysis

17:30 - 18:00

Final Questions and Answers - Wrap up - Prize
Draw

Most common method validation pitfalls and how to
avoid them

Going through most frequently asked questions

Final questions and answers and wrap-up

At the end there will a lucky draw for valuable
prizes, for example for the Labcompliance Package ($599)
and Labcompliance Users Club ($379)

Course registration fee

2500 Rubin, including copies of all slides

Reference Material for Easy Implementation

70-page e booklet written by Dr. Ludwig Huber about
"Validation of Analytical Procedures"

About the course director

Ludwig Huber,
Ph.D., is Director for global FDA compliance at Labcompliance. He is
the author and editor of
www.labcompliance.com, the on-line resource for validation and
laboratory compliance.

He studied
chemistry and received his PhD. from the University of
Karlsruhe, Germany. He is also the author of the
bestselling books “Validation of Computerized Analytical
Systems” and “Validation and Qualification in Analytical
Laboratories,”.

He
has given multiple presentations mainly on GLP/GMP, 21 CFR Part
11 and Validation around the world. This included seminars and
presentations for the US FDA, ISPE, PDA, PIC/S and several
national health agencies. For more information, please check the
website:
http://www.ludwig-huber.com

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from an IVT conference conference with Ludwig
Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP Special interest group (SIG) on
Laboratory Computers, PDA Part 11 task force, IVT task force on
network infrastructure qualification and the European Compliance
Academy. He frequently visits FDA in Rockville, VA, and participates
in panel discussions with FDA professionals.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith,
FDA's national Part11 expert, at a panel discussion with
Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about
computer system validation and e-records.

First International GLP Award from Indian Drug Manufacturer
Association

Dr. Ludwig Huber, Chief Advisor and Editor of Labcompliance,
received the First International GLP award for his research
and publications on GLP and GMP from the Indian Drug
Manufacturer Association (IMDA). The winner has been a
selected by a committee of members from the Advisory Board
of IMDA

Dr. Ludwig Huber
from Agilent Technologies received IDMA's First
International GLP Award from the president Mr. Isran

Ludwig Huber
presenting the key note address

All IDMA award
winners together with the organization committee. Main
attraction was Ludwig Huber with flowers in the middle.

Ludwig Huber
donating his two validation reference books to Mr.
Sipahilanami for the IDMA

Ludwig Huber has
been interviewed by two journalists.

They asked him about his view on positioning of Indian
Pharmaceutical industry in global market place.

Ludwig Huber
celebrating this success in a fine restaurant with his
favorite colleges and friends from Agilent India, Sanjev
Dhar and Ganapathy Ramakrishnan (Rama, right), country
manager of Agilent India